Polyrizon receives IRB approval for NASARIX™ clinical trial to block airborne allergens in patients with allergic rhinitis.
Quiver AI Summary
Polyrizon Ltd. announced it has received central IRB approval to initiate its first human clinical trial for NASARIX™, an intranasal spray designed to block airborne allergens. The approval, granted by BRANY Institutional Review Board on June 18, 2026, confirms that the study protocol and related materials have met ethical and participant protection standards. The trial, titled "Evaluation of the Efficacy, Safety, and Tolerability of NASARIX™ Allergy Blocker Compared to Saline Spray in Patients with Seasonal Allergic Rhinitis," will evaluate NASARIX™'s effectiveness against a saline control. CEO Tomer Izraeli expressed the significance of this milestone as they move towards site activation and patient enrollment. The study is valid until June 2027, contingent on ongoing regulatory compliance. Polyrizon specializes in developing innovative medical device hydrogels aimed at creating protective barriers in the nasal cavity.
Potential Positives
- Polyrizon has received central IRB approval for its first human clinical trial of NASARIX™, marking a significant regulatory milestone for the company.
- The approved study aims to assess the efficacy, safety, and tolerability of NASARIX™ in treating seasonal allergic rhinitis, highlighting the potential therapeutic impact of the product.
- This approval is a crucial step towards patient enrollment and site activation, indicating progress in the company's clinical development program.
Potential Negatives
- The company is still in a development stage and has not yet completed human clinical trials, which implies that its products are not yet commercially available and may face challenges in achieving market readiness.
- There is inherent uncertainty in the success of the clinical trials, and the forward-looking statements indicate that there is no assurance of achieving their projected outcomes.
- The company must obtain separate site-specific approvals for clinical trial sites, which could delay progress and raise regulatory hurdles potentially impacting timelines and operations.
FAQ
What is NASARIX™ developed by Polyrizon?
NASARIX™ is a proprietary nasal spray designed to block airborne allergens and manage seasonal allergic rhinitis.
When did Polyrizon receive IRB approval for NASARIX™?
Polyrizon received central IRB approval on June 18, 2026, for its first human clinical trial of NASARIX™.
What is the purpose of the NASARIX™ clinical trial?
The trial aims to evaluate NASARIX™'s efficacy, safety, and tolerability compared to saline spray in patients with seasonal allergic rhinitis.
How long is the IRB approval for NASARIX™ valid?
The IRB approval is valid through June 17, 2027, pending ongoing oversight and compliance.
What is unique about Polyrizon's hydrogel technology?
Polyrizon's hydrogel technology creates a protective barrier in the nasal cavity to prevent allergens from contacting nasal tissues.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$PLRZ Insider Trading Activity
$PLRZ insiders have traded $PLRZ stock on the open market 6 times in the past 6 months. Of those trades, 0 have been purchases and 6 have been sales.
Here’s a breakdown of recent trading of $PLRZ stock by insiders over the last 6 months:
- TOMER IZRAELI (Chief Executive Officer) has made 0 purchases and 2 sales selling 4,400 shares for an estimated $48,435.
- OZ ADLER sold 3,292 shares for an estimated $39,668
- TIDHAR TURGEMAN (Chief Technology Officer) sold 2,917 shares for an estimated $31,795
- LIRON CARMEL has made 0 purchases and 2 sales selling 1,042 shares for an estimated $12,743.
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$PLRZ Hedge Fund Activity
We have seen 3 institutional investors add shares of $PLRZ stock to their portfolio, and 3 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- FNY INVESTMENT ADVISERS, LLC added 24,575 shares (+inf%) to their portfolio in Q1 2026, for an estimated $287,036
- JANE STREET GROUP, LLC removed 14,032 shares (-100.0%) from their portfolio in Q1 2026, for an estimated $163,893
- CITADEL ADVISORS LLC added 10,149 shares (+inf%) to their portfolio in Q1 2026, for an estimated $118,540
- LEGACY WEALTH MANAGMENT, LLC/ID added 1,150 shares (+inf%) to their portfolio in Q1 2026, for an estimated $13,432
- UBS GROUP AG removed 1,025 shares (-100.0%) from their portfolio in Q1 2026, for an estimated $11,972
- CITIGROUP INC removed 12 shares (-92.3%) from their portfolio in Q1 2026, for an estimated $140
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard. You can access data on hedge funds moves and 13F filings through the Quiver Quantitative API 13F endpoint.
Full Release
Raanana, Israel, June 29, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the “Company” or “Polyrizon”), a development-stage biotech company specializing in the development of innovative intranasal hydrogels, announced it has received central IRB approval to begin its first human clinical trial for NASARIX™ , the Company’s innovative nasal spray designed to block airborne allergens.
This approval from BRANY Institutional Review Board (granted June 18, 2026) is a key regulatory milestone for the Company. It confirms that the study protocol, patient consent forms, and trial materials have been reviewed and approved by the central IRB and satisfy applicable ethical and participant protection requirements.
The approved study, titled “Evaluation of the Efficacy, Safety, and Tolerability of NASARIX TM Allergy Blocker Compared to Saline Spray in Patients with Seasonal Allergic Rhinitis,” is designed to assess the efficacy, safety, and tolerability of NASARIX TM in patients suffering from seasonal allergic rhinitis. The study will compare NASARIX TM against a saline spray control to evaluate symptom relief and overall patient outcomes.
The IRB reviewed and approved the clinical protocol (PL14-CTP-01), associated instructions for use, informed consent documents, quality-of-life assessments, and electronic diary tools that will be used during the study.
“This IRB approval represents an important milestone in the advancement of our NASARIX TM clinical development program,” said Tomer Izraeli, CEO. “We are pleased to have received approval for the study master file and look forward to progressing toward site activation and patient enrollment following completion of site-specific IRB approvals.”
The BRANY approval applies to the study’s master protocol and supporting documentation. Individual clinical sites must obtain separate site-specific approvals before initiating study-related activities or enrolling participants.
The approval remains valid through June 17, 2027, subject to ongoing IRB oversight and regulatory compliance requirements.
About NASARIX TM
NASARIX TM is Polyrizon’s proprietary nasal spray designed to create a protective barrier within the nasal cavity, helping to prevent contact between inhaled allergens and the nasal mucosa. The product is being developed as a non-drug approach for the management of seasonal allergic rhinitis.
About Polyrizon
Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM , or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target, or T&T. For more information, please visit https://polyrizon-biotech.com .
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the the timing and progress of its clinical trials and progressing toward site activation and patient enrollment following completion of site-specific IRB approvals. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites.
Contacts:
Michal Efraty
Investor Relations
[email protected]